A Congressional committee opened an investigation of three direct-to-consumer genetic testing companies this week.
The House's Committee on Energy and Commerce sent requests to the CEOs of 23andme, Navigenics and Pathway Genomics for a wide array of information about the companies' services.
The letters, co-signed by Henry Waxman (D-California), Joe Barton (R-Texas), Bart Stupak (D-Michigan), and Michael Burgess (R-Texas), ask for all documents dating from January 1, 2007 to the present.
First, the committee wants "a chart listing the conditions, diseases, consumer drug responses, and adverse reactions" for which the companies' test and "all policy documents, training manuals, or written guidance" about their counseling policies. They also requested all documents related to how the companies identify the risk to consumers based on their genomic profiles, and how they process and use individual DNA samples.
Add it all up and the documents could be the starting point for a wide-ranging investigation, if the committee decides to go down that road.
The companies have until June 4 to return all the requested documents to the Subcommittee on Oversight and Investigations, chaired by Stupak.
The moves appear to be a response to media reports that Pathway Genomics hoped to sell its genetic testing kits in retail locations like Walgreens, "despite concern from the scientific community regarding the accuracy of the test results." The House committee letter cited two New York Times stories about the plans.
Requests for comment from 23andme, Navigenics, Pathway Genomics and the House committee were not answered. Personal genomics company 23andme released a short statement but would not answer questions.
"We will comply with the Committee on Energy and Commerce’s request for information," the statement reads. "We look forward to sharing information detailing what individuals can learn about their own bodies through personal genetic testing and how our company is facilitating important scientific research in the field."
The direct-to-consumer genetic testing companies briefly found themselves in hot water with state regulators in New York and California in the summer of 2008. After they resolved those situations, they've had a relatively free ride from regulators, which appears to be ending.
Beyond the Congressional inquiry, the Food and Drug Administration recently went after Pathway for its retail plan. That spooked the would-be retailers, who decided offering genetic tests on their shelves was not such a good idea.
"We think this would be an illegally marketed device if they proceed," Alberto Gutierrez, director of the FDA's office of in-vitro diagnostics told the Washington Post. "They are making medical claims. We don't know whether the test works and whether patients are taking actions that could put them in jeopardy based on the test."
While many industry watchers have long suspected regulators would eventually pay more attention to the industry, but so far, it's unclear what Congress or the FDA have in store for the genetic testing companies.
Image: flickr/Drew Olanoff
See Also:
- Thomas Goetz on Why the Debate Over Personal Genomics Is a False One
- 23AndMe Will Decode Your DNA for $1,000. Welcome to the Age of Genomics
- Genetic-Testing Company Details Regulatory Defense Plan
- Should Medicare Pay for Genetic Testing?
- Regulators, Genetic Testing Companies Begin Face Off
- Are Internet Genetic Testing Services Really Illegal?
- Meeting Reveals California's Hardline Stance on DNA Testing
- Top 10 Reasons that Regulators Should Not Hinder Genetic Testing
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